What are the responsibilities and job description for the Quality Engineer position at Maximus Tech Inc?
Position Summary
The Quality Engineer will support quality assurance activities across the product lifecycle — from design and manufacturing through post-market surveillance — for Class I/II medical devices. This is an excellent opportunity for an early-career engineer to build a strong foundation in medical device quality systems, FDA regulations, and ISO standards while working closely with cross-functional teams including Manufacturing, R&D, Regulatory Affairs, and Supplier Quality.
Key Responsibilities
- Support implementation and maintenance of the Quality Management System (QMS) in compliance with 21 CFR Part 820 (QSR) and ISO 13485.
- Assist in developing, reviewing, and executing inspection plans, test protocols, and acceptance criteria for incoming, in-process, and final inspection.
- Participate in root cause investigations, Corrective and Preventive Actions (CAPA), and Non-Conformance Report (NCR) resolution.
- Support internal audits and assist in preparing documentation for external/regulatory audits (FDA, Notified Body, customer audits).
- Assist with risk management activities in accordance with ISO 14971, including FMEA support.
- Support Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) documentation and maintenance.
- Collect, analyze, and report quality metrics (scrap rates, yield, complaint trends, CAPA aging, etc.).
- Participate in validation activities (IQ/OQ/PQ) for equipment and processes under supervision.
- Support supplier quality activities, including incoming inspection criteria and basic supplier corrective action follow-up.
- Assist with complaint handling and Medical Device Reporting (MDR) documentation as needed.
- Collaborate with Manufacturing and Engineering teams to identify and drive process/quality improvements.
- Maintain accurate, audit-ready documentation in compliance with Good Documentation Practices (GDP).
Required Qualifications
- Bachelor's degree in Engineering (Biomedical, Mechanical, Industrial, Manufacturing, Chemical) or related field.
- 0–2 years of experience in a quality, manufacturing, or engineering role (internships and co-ops count).
- Basic understanding of quality systems and regulatory requirements for medical devices (21 CFR 820, ISO 13485) preferred; willingness to learn required.
- Familiarity with root cause analysis tools (5 Why, Fishbone/Ishikawa, Pareto analysis) is a plus.
- Strong attention to detail and commitment to accuracy in documentation.
- Proficiency in Microsoft Office (Excel, Word); familiarity with statistical tools (Minitab, JMP) is a plus.
- Good written and verbal communication skills.
- Ability to work onsite and collaborate cross-functionally in a team environment
Preferred Qualifications
- Coursework or exposure to GD&T, statistical process control (SPC), or basic metrology.
- Exposure to ISO 14971 risk management concepts.
- ASQ Certified Quality Engineer (CQE) — in progress or interest in pursuing is a plus.